BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4844999 · Received June 15, 2015

    Report

    Report Number
    2016493-2015-00474
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 28, 2015
    Report Date
    June 5, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A 120ML INFUSION OF LIPIDS RUNNING AT A RATE OF 10ML/HR AND COMPLETING IN 2.5 HOURS WAS NOT CONFIRMED. PHYSICAL INSPECTION NOTED THE DEVICE TO BE IN OVERALL GOOD CONDITION WITH NO ANOMALIES NOTED AND THE INSTRUMENT SEAL INTACT. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT AT 4:37 PM ON (B)(6) 2015 THE MODULE WAS PROGRAMMED TO INFUSE LIPID EMULSION 20% AT 10ML/HR WITH A VTBI OF 120ML. THE PUMP MODULE WAS CHANNELED OFF 3 HOURS AND 40 MINUTES LATER. THERE WERE NO ALARMS DURING THE INFUSION. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 36.579ML. FUNCTIONAL TESTING WAS PERFORMED AND FOUND THE PUMP MODULE TO BE DELIVERING FLUID WITHIN SPECIFICATION. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A 120 ML BAG WITH LIPIDS WAS SUPPOSED TO INFUSE AT 10ML/HR AND SHOULD HAVE LASTED UNTIL 5AM, HOWEVER IT BUT COMPLETED IN 2.5 HRS AND WAS INFUSED BY 1930. ALTHOUGH THE NURSE INDICATED SHE PROGRAMMED THE DEVICE CORRECTLY, THE CUSTOMER STATED THEY ARE NOT SURE IF THERE WAS A DEVICE MALFUNCTION OR IF THE DEVICE WAS PROGRAMMED INCORRECTLY. THERE IS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389760 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1